Class II — Response Biomedical Corp.
| Recalling firm | Response Biomedical Corp. |
|---|---|
| Registered facility | Response Biomedical Corp. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months. |
| Product | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP® platform. |
| Quantity | 543 units |
| Distribution | Worldwide distribution: US Nationwide distributions in the states of IN, GA, OK, KS, AZ, SC, NE, NC, MI, FL, CA, MN, and AR. Countries of Canada, Italy, Malaysia, Kuwait, Saudi Arabia, UAE, Ukraine, Russia, Dominican Republic, France, Mexico, Colombia, Singapore, China, Serbia, Romania, and Philippine. |
| Initiated | 2019-03-15 |
| Classified | 2020-03-10 |
| Terminated | 2022-06-09 |
| Recall number | Z-1461-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Response Biomedical Corp. (Z-1461-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84514/
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